Method of using an indwelling catheter apparatus including disposable anti-microbial sleeve

ABSTRACT

A method of using a disposable catheter sleeve to prevent infection. A method of using an indwelling catheter apparatus including a catheter tube comprising a first end for insertion into a patient&#39;s body and a disposable catheter sleeve wrapped around the catheter tube proximate to the first end of the catheter tube to prevent infection.

CROSS-REFERENCE(S) TO RELATED APPLICATION(S)

This application claims priority to and is a continuation-in-part ofpending U.S. nonprovisional patent application Ser. No. 16/937,649entitled “INDWELLING CATHETER APPARATUS INCLUDING DISPOSABLEANTI-MICROBIAL SLEEVE” which was filed on Jul. 24, 2020, the entirety ofwhich is incorporated herein by reference.

FIELD

This disclosure relates to the field of indwelling catheters. Moreparticularly, this disclosure relates to an indwelling catheterapparatus including a removable, disposable antimicrobial sleeve.

BACKGROUND

One type of catheter technology in the medical fields includesindwelling catheters, some of which are often referred to in the medicalfield as “Foley” catheters. A distal end of such catheters is insertedinto a patient's urethra into the patient's bladder. Often, patientsthat have catheters inserted also suffer from incontinence. When a bowelmovement occurs, fecal matter often winds up on a catheter tubeproximate to where such catheter tube is inserted into the patient'surethra. As such, catheter tubes near a patient's urethra must becleaned often to remove such fecal matter. When traces of fecal matterremain on the catheter tube, bacteria grow or move up along the cathetertube into a patient's urethra, thereby causing a urinary tract and/orbladder infection. In extreme cases, such infections can lead to deathof the patient. In less extreme cases, hospitals are tasked with payingfor any such infection caused by the conditions of a patient's cathetertube when such tubes are not promptly and properly cleaned to avoid suchinfections.

What is needed, therefore, is a device and method to help keep cathetertubes clean and as sterile as possible and also making the cleaning ofcatheter tubes easier.

SUMMARY

The above and other needs are met by an indwelling catheter apparatuscomprising a catheter tube comprising a first end for insertion into apatient's body; and a disposable catheter sleeve wrapped around thecatheter tube proximate to the first end of the catheter tube. Thedisposable catheter sleeve may further include a sleeve body including afirst layer of elastic material. The first layer may include anantimicrobial agent. The sleeve body may also include a second layer (aninternal layer) including an antimicrobial agent. The sleeve body mayalso include a third layer (an outer layer) including an antimicrobialagent. The disposable catheter sleeve may further include a lengthwiseslit along the disposable catheter sleeve for wrapping the disposablecatheter sleeve around the catheter tube. The disposable catheter sleevemay further include an aperture along the disposable catheter sleeve fora fluid port.

In another aspect, embodiments of the disclosure provide a disposablecatheter sleeve for wrapping around a catheter tube proximate to where acatheter tube is inserted into a patient, the disposable catheter sleevecomprising an elastic sleeve body including a first end and a secondend; and a lengthwise slit along the sleeve body from the first end tothe second end. The sleeve body may further include a first layer ofelastic material. The first layer may include an antimicrobial agent.The sleeve body may also include a second layer (an internal layer) ofantimicrobial material extending at least partially along a length ofthe first layer. The sleeve body may also include a third layer (anouter layer) of antimicrobial material extending at least partiallyalong a length of the first layer. The disposable catheter sleeve mayfurther include an aperture along the elastic sleeve body. The firstlayer is preferably made of a material such as a polymer-based materialsuch as plastic. Specific examples of materials that can be used includesoft plastic, silicone rubber and latex. Other examples include nitinol,nylon, polyurethane, thermoplastic elastomers and polyethyleneterephthalate. The antimicrobial agent(s) used in the second layerand/or the third layer may include for example, a quaternary ammoniumcompound, chlorhexidine, chloroxylenol, a fungal inhibitor, and/or anantimicrobial peptide (AMP). The antimicrobial agent may include abactericide such as, for example, gentamicin, cephalothin,carbenicillin, amoxicillin, cefamandol, tobramycin, and vancomycin.

In another aspect, embodiments of the disclosure provide a method ofusing an indwelling catheter apparatus including a disposable cathetersleeve to prevent to prevent infection, the method comprising insertinga first end of a catheter tube into a medical patient's urethra; andwrapping a first disposable catheter sleeve around the catheter tube ata location proximate to an insertion point of the catheter tube into themedical patient's body wherein the first disposable catheter sleevecomprises a first disposable catheter sleeve body including a firstlayer and wherein the first disposable catheter sleeve body includes afirst disposable catheter sleeve body first end and a first disposablecatheter sleeve body second end. The first disposable catheter sleevemay further comprise an antimicrobial agent. The first disposablecatheter sleeve may further comprise a second layer including anantimicrobial agent wherein the second layer is disposed internal to thefirst layer. The first disposable catheter sleeve may further comprise athird layer including an antimicrobial agent wherein the third layer isdisposed external to the first layer. The first disposable cathetersleeve may further comprise a first lengthwise slit along the firstdisposable catheter sleeve from the first disposable catheter sleevefirst end to the first disposable catheter sleeve second end forwrapping the first disposable catheter sleeve around the catheter tube.The first disposable catheter sleeve may further comprise an aperturealong the disposable catheter sleeve for circumnavigating a fluid port.The first layer may be made of a material comprising an elasticpolymer-based material. The antimicrobial agent may comprise a memberselected from the group consisting of a quaternary ammonium compound,chlorhexidine, chloroxylenol, a fungal inhibitor, and an antimicrobialpeptide. The antimicrobial agent may comprise a bactericide selectedfrom the group consisting of gentamicin, cephalothin, carbenicillin,amoxicillin, cefamandol, tobramycin, and vancomycin. The method mayfurther comprise removing the first disposable catheter sleeve from thecatheter tube; and wrapping a second disposable catheter sleeve aroundthe catheter tube at the location proximate to an insertion point of thecatheter tube into the medical patient's body wherein the seconddisposable catheter sleeve comprises a second disposable catheter sleevebody including a first layer and wherein the second disposable cathetersleeve body includes a second disposable catheter sleeve body first endand a second disposable catheter sleeve body second end.

The summary provided herein is intended to provide examples ofparticular disclosed embodiments and is not intended to cover allpotential embodiments or combinations of embodiments. Therefore, thissummary is not intended to limit the scope of the invention disclosurein any way, a function which is reserved for the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features, aspects, and advantages of the present disclosure willbecome better understood by reference to the following detaileddescription, appended claims, and accompanying figures, wherein elementsare not to scale so as to more clearly show the details, wherein likereference numbers indicate like elements throughout the several views,and wherein:

FIG. 1 shows a perspective view of a disposable protective sleeve foruse along a catheter tube where a catheter is inserted into a patient;

FIG. 2 shows a plan view of the disposable protective sleeve shown inFIG. 1;

FIG. 3 shows an end view of the disposable protective sleeve shown inFIG. 1 and FIG. 2;

FIG. 4 shows a perspective view of a disposable protective sleeveincluding an inner antimicrobial layer for use along a catheter tubewhere a catheter is inserted into a patient;

FIG. 5 shows a plan view of the disposable protective sleeve shown inFIG. 4;

FIG. 6 shows an end view of the disposable protective sleeve shown inFIG. 4 and FIG. 5;

FIG. 7 shows a perspective view of a disposable protective sleeveincluding an inner antimicrobial layer and an outer antimicrobial layerfor use along a catheter tube where a catheter is inserted into apatient;

FIG. 8 shows a plan view of the disposable protective sleeve shown inFIG. 7;

FIG. 9 shows an end view of the disposable protective sleeve shown inFIG. 7 and FIG. 8;

FIG. 10 shows an image of an indwelling catheter apparatus including aprotective sleeve from FIGS. 4-6 engaged therewith at a locationproximate to where the catheter apparatus would be inserted into apatient.

FIG. 11 shows a perspective view of a disposable protective sleeveincluding an inner antimicrobial layer for use along a catheter tubewhere a catheter is inserted into a patient and wherein the sleeveincludes an aperture;

FIG. 12 shows a plan view of the disposable protective sleeve shown inFIG. 11;

FIG. 13 shows an end view of the disposable protective sleeve shown inFIG. 11 and FIG. 12;

FIG. 14 shows an image of an indwelling catheter apparatus including aprotective sleeve shown in FIGS. 11-13 engaged therewith at a locationproximate to where the catheter apparatus would be inserted into apatient; and

FIG. 15 shows a flowchart describing a method of using the indwellingcatheter apparatuses and disposable indwelling catheter sleevesdescribed herein.

The figures are provided to illustrate concepts of the inventiondisclosure and are not intended to embody all potential embodiments ofthe invention. Therefore, the figures are not intended to limit thescope of the invention disclosure in any way, a function which isreserved for the appended claims.

DETAILED DESCRIPTION

Various terms used herein are intended to have particular meanings. Someof these terms are defined below for the purpose of clarity. Thedefinitions given below are meant to cover all forms of the words beingdefined (e.g., singular, plural, present tense, past tense). If thedefinition of any term below diverges from the commonly understoodand/or dictionary definition of such term, the definitions belowcontrol.

FIGS. 1-3 shows an embodiment of a disposable catheter sleeve 100including a first end 102A and a second end 102B. The sleeve 100includes a slit 104 cut lengthwise along the sleeve 100 from the firstend 102A to the second end 102B. FIG. 2 shows a plan view of the sleeve100 showing the slit 104. The sleeve may include a single layer 106 ofelastic material such as for example, a polymer-based material such asplastic. Specific examples of materials that can be used include softplastic, silicone rubber and latex. Other examples include nitinol,nylon, polyurethane, thermoplastic elastomers and polyethyleneterephthalate. FIG. 3 shows an end view of the sleeve. Preferably, thematerial selected for the sleeve preferably includes an antimicrobialagent. The antimicrobial agent may include, for example, a quaternaryammonium compound, chlorhexidine, chloroxylenol, a fungal inhibitor,and/or an antimicrobial peptide (AMP). The antimicrobial agent mayinclude a bactericide such as, for example, gentamicin, cephalothin,carbenicillin, amoxicillin, cefamandol, tobramycin, and vancomycin.

In an alternative embodiment shown in FIGS. 4-6, a disposable cathetersleeve 200 is shown including a first end 202A and a second end 202B.The sleeve 200 includes a slit 204 cut lengthwise along the sleeve 200from the first end 202A to the second end 202B. FIG. 5 shows a plan viewof the sleeve 200 showing the slit 204. The sleeve 200 preferablyincludes a first layer 208 made of an elastic material such as apolymer-based material such as plastic and a second layer 210—anantimicrobial inner layer including an antimicrobial agent. Specificexamples of materials that can be used for the first layer 208 includesoft plastic, silicone rubber and latex. Other examples include nitinol,nylon, polyurethane, thermoplastic elastomers and polyethyleneterephthalate. The antimicrobial agent may include, for example, aquaternary ammonium compound, chlorhexidine, chloroxylenol, a fungalinhibitor, and/or an antimicrobial peptide (AMP). The antimicrobialagent may include a bactericide such as, for example, gentamicin,cephalothin, carbenicillin, amoxicillin, cefamandol, tobramycin, andvancomycin. FIG. 6 shows an end view of the sleeve 200 showing the firstlayer 208 and the second layer 210. In some embodiments theantimicrobial inner layer 210 extends along the entire length of thefirst layer 208 and in other embodiments the antimicrobial inner layer210 only extends part of the length of the outer layer 208.

In yet another embodiment shown in FIGS. 7-9, a disposable cathetersleeve 300 is shown including a first end 302A and a second end 302B.The sleeve 300 includes a slit 304 cut lengthwise along the sleeve 300from the first end 302A to the second end 302B. FIG. 8 shows a plan viewof the sleeve 300 showing the slit 304. The sleeve 300 preferablyincludes a first layer 308 made of an elastic material such as apolymer-based material such as plastic. Specific examples of materialsthat can be used for the first layer 308 include soft plastic, siliconerubber and latex. Other examples include nitinol, nylon, polyurethane,thermoplastic elastomers and polyethylene terephthalate. The sleeve 300further includes a second layer 310—an antimicrobial inner layerincluding an antimicrobial agent. The antimicrobial agent may include,for example, a quaternary ammonium compound, chlorhexidine,chloroxylenol, a fungal inhibitor, and/or an antimicrobial peptide(AMP). The antimicrobial agent may include a bactericide such as, forexample, gentamicin, cephalothin, carbenicillin, amoxicillin,cefamandol, tobramycin, and vancomycin. The sleeve 300 further includesa third layer 312—an antimicrobial outer layer including anantimicrobial agent such as the antimicrobial agent(s) used in thesecond layer 310. FIG. 9 shows an end view of the sleeve 300 showing thefirst layer 308, the second layer 310, and the third layer 312. In someembodiments the antimicrobial inner layer 310 and the antimicrobialouter layer 312 extend along the entire length of the first layer 308and in other embodiments the antimicrobial inner layer 310 and theantimicrobial outer layer 312 only extend part of the length of thefirst layer 308.

The disposable catheter sleeves described herein (100, 200, or 300) arepreferably used on an indwelling catheter apparatus 400 shown in FIG.10. The indwelling catheter apparatus 400 includes a catheter tube 402including a first end 404A and a second end 404B. The first end 404A isconfigured for insertion into a patient's body. In the case of a Foleycatheter, such insertion occurs in the patient's urethra. The disposablecatheter sleeve (100, 200, or 300) is preferably wrapped around thecatheter tube 402 at a location proximate to the interface between apatient's body and the catheter tube 402. As such, the disposablecatheter sleeve (100, 200 or 300) is typically not situated at the firstend 404A of the catheter tube 402 but is some distance from first end404A of the catheter tube 402. Because patients may vary in size, thedisposable catheter sleeve (100, 200 or 300) is preferably added to thecatheter tube 402 after the first end 404A of the catheter tube 402 hasbeen inserted into a patient's urethra. The indwelling catheterapparatus 400 may further include the second end 404B of the cathetertube 402 in communication with a liquid collection bag 406, Theindwelling catheter apparatus 400 typically includes a port 408 foraccess to the catheter tube 402. Such port can be used, for example, asa balloon port for inflating a balloon near the first end 404A of thecatheter tube 402.

In an alternative embodiment shown in FIGS. 11-13, a disposable cathetersleeve 500 is shown including a first end 502A and a second end 502B.The sleeve 500 includes a slit 504 cut lengthwise along the sleeve 500from the first end 502A to the second end 502B and an aperture 506 alongthe sleeve for a balloon port or other additional port. In thisembodiment, and others like it, the sleeve 500 is longer, therebyrequiring the aperture 506 for the sleeve 500 to fit around a cathetertube and circumnavigate any port such as the port 408 shown below inFIG. 14. FIG. 12 shows a plan view of the sleeve 500 showing the slit504. The sleeve 500 preferably includes a first layer 508 made of anelastic material such as a polymer-based material such as plastic and asecond layer 510—an antimicrobial inner layer including an antimicrobialagent. In other similar embodiments including an aperture like aperture506, such sleeves may include only the first layer 508 and others mayinclude the first layer 508, the second layer 510, and a thirdantimicrobial outer layer similar to the third layer 312 shown in theembodiment in FIGS. 7-9. Specific examples of materials that can be usedfor the first layer 508 include soft plastic, silicone rubber and latex.Other examples include nitinol, nylon, polyurethane, thermoplasticelastomers and polyethylene terephthalate. The antimicrobial agent mayinclude, for example, a quaternary ammonium compound, chlorhexidine,chloroxylenol, a fungal inhibitor, and/or an antimicrobial peptide(AMP). The antimicrobial agent may include a bactericide such as, forexample, gentamicin, cephalothin, carbenicillin, amoxicillin,cefamandol, tobramycin, and vancomycin. FIG. 13 shows an end view of thesleeve 500 showing the first layer 508 and the second layer 510. In someembodiments the antimicrobial inner layer 510 extends along the entirelength of the first layer 508 and in other embodiments the antimicrobialinner layer 510 only extends part of the length of the outer layer 508.

The disposable catheter sleeve 500 and related embodiments arepreferably used on the indwelling catheter apparatus 400 shown in FIG.14. The indwelling catheter apparatus 400 includes the catheter tube 402including the first end 404A and the second end 404B. The first end 404Ais configured for insertion into a patient's body. The disposablecatheter sleeve 500 is preferably wrapped around the catheter tube 402at a location proximate to the interface between a patient's body andthe catheter tube 402. As such, the disposable catheter sleeve 500 istypically not situated at the first end 404A of the catheter tube 402but is some distance from first end 404A of the catheter tube 402.Because patients may vary in size, the disposable catheter sleeve 500 ispreferably added to the catheter tube 402 after the first end 404A ofthe catheter tube 402 has been inserted into a patient's urethra. Theindwelling catheter apparatus 400 may further include the second end404B of the catheter tube 402 in communication with a liquid collectionbag 406. The catheter sleeve 500 includes the aperture 506 so that thesleeve 500 can circumnavigate the port 408 extending out of the cathetertube 402.

In addition to Foley catheters, the disposable catheter sleeve may alsobe used with other indwelling catheters such as, for example, suprapubiccatheters.

In addition to the embodiments of catheter sleeves described above, alsodisclosed herein is a method of using such catheter sleeves. The methodpreferably includes inserting a first end of a catheter tube into amedical patient's urethra (600), wrapping a first disposable cathetersleeve around the catheter tube at a location proximate to an insertionpoint of the catheter tube into the medical patient's body (602). Thefirst disposable catheter sleeve may be any of the catheter sleevesdescribed herein or variations thereof including any features of suchsleeves described above. The method may further include removing thefirst disposable catheter sleeve from the catheter tube (604) andwrapping a second disposable catheter sleeve around the catheter tube atthe location proximate to an insertion point of the catheter tube intothe medical patient's body (606). The second disposable catheter sleevemay be any of the catheter sleeves described herein or variationsthereof including any features of such sleeves described above.

The previously described embodiments of the present disclosure have manyadvantages including use of the disposable catheter sleeve which helpskeep the catheter tube 402 clean. If a patient has a bowel movement andfecal matter ends up on the catheter sleeve, the disposable cathetersleeve and associated fecal matter can be removed with the fecal matterand a new disposable catheter sleeve can be added quickly in place ofthe old one. To the extent that any fecal matter or other materialincluding bacteria or which increases the risk of bacterial growth getsbeneath any disposable catheter sleeve including an antimicrobial innerlayer, the antimicrobial inner layer helps to kill bacteria and minimizebacterial growth before the catheter tube 402 can be cleaned and a newdisposable catheter sleeve applied to the catheter tube 402. By killingand minimizing bacteria, these various features decrease the chance forinfection of the patient, thereby decreasing the risk for seriouscomplications from infection. The various features also help lowerhospital operating costs for handling infections because the infectionrate will be decreased by use of the disposable catheter sleeve andother antimicrobial features.

The foregoing description of preferred embodiments of the presentdisclosure has been presented for purposes of illustration anddescription. The described preferred embodiments are not intended to beexhaustive or to limit the scope of the disclosure to the preciseform(s) disclosed. Obvious modifications or variations are possible inlight of the above teachings. The embodiments are chosen and describedin an effort to provide the best illustrations of the principles of thedisclosure and its practical application, and to thereby enable one ofordinary skill in the art to utilize the concepts revealed in thedisclosure in various embodiments and with various modifications as aresuited to the particular use contemplated. All such modifications andvariations are within the scope of the disclosure as determined by theappended claims when interpreted in accordance with the breadth to whichthey are fairly, legally, and equitably entitled.

Any element in a claim that does not explicitly state “means for”performing a specified function, or “step for” performing a specificfunction, is not to be interpreted as a “means” or “step” clause asspecified in 35 U.S.C. § 112, 116. In particular, the use of “step of”in the claims herein is not intended to invoke the provisions of 35U.S.C. § 112, 116.

What is claimed is:
 1. A method of using an indwelling catheterapparatus including a disposable catheter sleeve to prevent to preventinfection, the method comprising: a. inserting a first end of a cathetertube into a medical patient's urethra; b. wrapping a first disposablecatheter sleeve around the catheter tube at a location proximate to aninsertion point of the catheter tube into the medical patient's bodywherein the first disposable catheter sleeve comprises a firstdisposable catheter sleeve body including a first layer and wherein thefirst disposable catheter sleeve body includes a first disposablecatheter sleeve body first end and a first disposable catheter sleevebody second end.
 2. The method of claim 1 wherein the first disposablecatheter sleeve further comprises an antimicrobial agent.
 3. The methodof claim 1 wherein the first disposable catheter sleeve furthercomprises a second layer including an antimicrobial agent wherein thesecond layer is disposed internal to the first layer.
 4. The method ofclaim 3 wherein the first disposable catheter sleeve further comprises athird layer including an antimicrobial agent wherein the third layer isdisposed external to the first layer.
 5. The method of claim 1 whereinthe first disposable catheter sleeve further comprises a firstlengthwise slit along the first disposable catheter sleeve from thefirst disposable catheter sleeve first end to the first disposablecatheter sleeve second end for wrapping the first disposable cathetersleeve around the catheter tube.
 6. The method of claim 3 wherein thefirst disposable catheter sleeve further comprises a first lengthwiseslit along the first disposable catheter sleeve from the firstdisposable catheter sleeve first end to the first disposable cathetersleeve second end for wrapping the first disposable catheter sleevearound the catheter tube.
 7. The method of claim 4 wherein the firstdisposable catheter sleeve further comprises a first lengthwise slitalong the first disposable catheter sleeve from the first disposablecatheter sleeve first end to the first disposable catheter sleeve secondend for wrapping the first disposable catheter sleeve around thecatheter tube.
 8. The method of claim 1 wherein the first disposablecatheter sleeve further comprises an aperture along the disposablecatheter sleeve for circumnavigating a fluid port.
 9. The method ofclaim 1 wherein the first layer is made of a material comprising anelastic polymer-based material.
 10. The method of claim 2 wherein theantimicrobial agent comprises a member selected from the groupconsisting of a quaternary ammonium compound, chlorhexidine,chloroxylenol, a fungal inhibitor, and an antimicrobial peptide.
 11. Themethod of claim 2 wherein the antimicrobial agent comprises abactericide selected from the group consisting of gentamicin,cephalothin, carbenicillin, amoxicillin, cefamandol, tobramycin, andvancomycin.
 12. The method of claim 1 further comprising: c. removingthe first disposable catheter sleeve from the catheter tube; and d.wrapping a second disposable catheter sleeve around the catheter tube atthe location proximate to an insertion point of the catheter tube intothe medical patient's body wherein the second disposable catheter sleevecomprises a second disposable catheter sleeve body including a firstlayer and wherein the second disposable catheter sleeve body includes asecond disposable catheter sleeve body first end and a second disposablecatheter sleeve body second end.